Device for connection with a closed container

ABSTRACT

Device (1) for sealing a closed container (2) comprising a neck (3), the opening (3a) of which is plugged, and provided with an external annular lip (3b), the device firstly comprising an internal cap (5) for fitting coaxially over the neck (3) of the plugged container (2), comprising catching teeth (6) distributed angularly about the axis (7) of the cap, each teeth having a radially outwards elasticity starting from a position (FIG. 3) of snap-fastening under the annular lip (3b), secondly, means (9) of access, which are arranged on the cap (5), and thirdly, an external sleeve (10) for sliding coaxially against and on the outside of the catching teeth (6), including a circumferentially continuous band (10a) provided along one of its edges with an internal annular ridge which may be continuous or discontinuous, for snap-fastening under the rim (6a), when the said sleeve (10) is in the fitted position. The band is radially elastic so that it can be fitted onto the cap when the annular ridge (11) is in the snap-fastened position, but strong so as to be indivisible, unless the said sleeve (10) is permanently destroyed.

BACKGROUND OF THE INVENTION

The present invention relates to connection with a closed containercomprising a neck, the opening of which is plugged by a stopper made ofa relatively soft material, for example made of elastomer, and providedwith an external annular lip, the said rigid container being, forexample, made of glass. As a non-exclusive preference, this connectionis used to provide communication between, on the one hand, theaforementioned closed container and, on the other hand, another closedcontainer comprising an end piece, the opening of which is also pluggedby a stopper made of a relatively soft and elastic material. Thisdefinition applies to various applications among which is includedtherapy or the administration of a medicinal product, in which case theclosed container contains, for example, an active ingredient in the formof a powder, and the other container consists of a flexible pouchcontaining a liquid medium which can dissolve the powder or activeingredient of the container or place it in suspension, this all being inorder to obtain a medicinal preparation in liquid form ready to beadministered to the patient.

A connection device, or connector, intended to be assembled in aleaktight manner, on the one hand, with a closed container as previouslydescribed, comprising tearable or puncturable tamperproofing meanskeeping the stopper sterile and, on the other hand, with anothercontainer as previously described, itself also comprising tearable orpuncturable tamperproofing means keeping the stopper present in theopening of the end fitting sterile without having to remove thetamperproofing means of the two containers to be connected, is describedand proposed in accordance with the document WO-9003536.

This connection device comprises:

a cap intended to fit coaxially over the neck of the container pluggedwith the stopper, and also covered around the annular lip by thetamperproofing means covering and sealing the whole of the external partof the stopper; this cap is also designed to be fitted over the neck 3and for this purpose has radially outward elasticity so that it cansnap-fasten, by means of an internal annular ridge, under the annularlip of the neck of the container; moreover, this cap comprises a coaxialcollar lengthening it and forming an internal bore, which will be dealtwith later,

a transverse element made of a flexible and elastic elastomericmaterial, attached to and arranged inside the cap, including atransverse wall designed to come into contact with the external part ofthe stopper; this transverse element comprises an axial end piece orsleeve tube fitted in a leaktight manner over the perforating end of theneedle which will be dealt with later, this sleeve tube being closed andperforable at its end sealing the needle,

means for connecting with the inside of the container, through thestopper, comprising a piston mounted so that it can slide in the bore ofthe collar of the cap, and a central needle passing through the saidpiston and including the aforementioned perforating end, capped insidethe sleeve tube or end piece of the transverse element made ofelastomer.

Such a device is not designed or suited to providing tamperproofing ofthe container with its stopper, because this tamperproofing is obtainedby other means already present on the container. In particular, thisdevice can be fitted and removed at will, relative to the pluggedcontainer.

Further, this device provides only temporary sealing, at the moment ofconnection, with each of the two containers in direct contact with theirown sealing means.

A device for connection with a closed container, as previously defined,and completely closing this container, but without tamperproofing it inthe sense that it is not put in place permanently on the container isdescribed in accordance with the document U.S. Pat. No. C4624667.

This device interacts with a specific, non-standardized container whichcan be distinguished from the one described earlier by the presence ofan annular rim running round the outside of the external annular lip andforming a housing for a flat, which is also annular, belonging to thestopper which in this case has a specific special shape.

The connection device proper comprises:

an axial and exterior sleeve tube which is of a single piece with thestopper made of elastomeric material, at its blind end forming amembrane which can be perforated by the central needle

means for connection with the inside of the container, these consistingsolely of a central or axial needle held in the aforementioned sleevetube by its perforating end,

a tubular cap sealed by a rim to the annular rim of the neck of thecontainer,

a protecting means or lid, lengthening the cap coaxially by use of amanual separation means, such as a circumferential line of weakness ofthe plastic, the lid and the cap together being arranged to cover theneedle of the connection means, and especially its other perforatingend, coaxially.

The cap previously described, of a single piece with the lid, does notfulfil a tamperproofing function in the sense that these elements may bedetached from the annular lip of the container either deliberately oraccidentally then put in place and bonded, for example, to this samelip, in which case the user has no visible indication or sign that theconnection device has been tampered with, and particularly that thesterile conditions, in the case of the connection device being used inpharmacy or in therapy has been broken.

SUMMARY OF THE INVENTION

The subject of the present invention is a connection device which iseffectively tamperproof, and in addition provides effective andpermanent sealing of the internal parts both during storage and use ofthe container, and does so in a simple manner. The objective of thissealing in particular is to preserve both the perforating end of theneedle of the connection means and the exterior part of the stopperlying inside the latter within the cap from any external contamination,particularly a break in the sterility of the container, irrespective ofthe conditions in which the connection device is used or stored.

In accordance with the invention, the following means work togethertowards this objective:

first of all, the cap is designed to fit directly over the neck of thecontainer, and come into contact with its wall,

the transverse wall of the cap is made of a relatively hard material sothat it comes directly to rest against the external part of the stopper,and it has a central opening for the passage of the needle from itsdisconnected position to its connected position, perforating thestopper,

in addition, an external sleeve is provided which is designed to slidecoaxially between and outside of the internal cap, having acircumferential continuous band, provided along one of its edges with aninternal annular ridge for snap-fastening under the free rim of theinternal cap; this band is sufficiently radially elastic to fit tightlyagainst the internal cap and clamp the latter and snap-fasten by meansof the annular ridge under the free edge of the internal cap, but strongenough to be indivisible, unless there is a desire to destroy it.

a means for protecting the connection means from the outside is alsoprovided, in leaktight contact with the collar of the cap.

All of this culminates in the volume lying between the piston of theconnection means, the inside of the collar and the exterior part of thestopper delimited by this cap being placed in a state of permanentleak-tightness which is maintained over time unless the connectiondevice is destroyed, this being achieved under conditions which make theconnection device tamperproof. This result is obtained, in particular,by simplifying construction of the connection device because the latterin particular has no axial or central elements attached inside theinternal cap for protecting the perforating end of the needle.

"Tamperproofing" or "tamperproof" is understood to be the characteristicor result by means of which the connection device cannot be dismantledand/or access to the inside of the container or to the product containedin the latter cannot be had without leaving a sign or indication of thisaccess which is durable, visible or detectable by the subsequent user ofthe container. In the present case, this sign or indication consists inthe partial or complete destruction of the integrity of the containerand/or of the connection device.

As regards a container containing a medicinal product, for example, byvirtue of the invention, on the one hand, the sterility within theconnection device cannot be broken without tampering with the deviceand/or the container and, on the other hand, any relative movementbetween the various parts or components of the connection device ispractically precluded or is in any case not sufficient to break thisseal.

"Leaktightness" or "seal" is understood to be the absence of the passageof any liquid, particularly a contaminated or non-sterile one, from theoutside towards the inside of the connection device, and/or contact ofthe stopper, during the normal conditions of use, handling or storage ofthe container, of course.

The way in which the technical features defined earlier work togetheralso afford additional advantages.

first of all, it makes it possible to make maximum use of the inherentviscoelastic properties of the stopper, in terms of sealing, both withrespect to the outside and with respect to the inside of the container.

the means of the invention also make it possible to get away withrelatively high tolerances both on the stopper in terms of thickness andon the annular lip of the container, also in terms of thickness, whichmeans that when the aforementioned tolerances are at a maximum, theinside of the connection device remains sealed to the outside.

the connection device remains compatible with all standard containers asused particularly in pharmacy, and in accordance with the standardsISO4362-3 or ISO8362-1,

the user has no visible or external means available which would allowhim easily to force or to tamper with the connection device once thelatter has been fitted permanently on the closed container.

and this device can easily be fitted on the already-closed containerwithout, in particular, modifying the lines or equipment used forpackaging the product contained in the said container.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is now described with reference to the attacheddrawing in which:

FIG. 1 represents, as an exploded view, a connection device inaccordance with the invention in relation to the stoppered or closedcontainer for which it is intended;

FIG. 2 represents one step in the fitting of the connection deviceaccording to FIG. 1, during which step the external sleeve istemporarily fitted over the internal cap, the latter being snap-fastenedunder the neck of the container;

FIG. 3 represents the connection device according to FIG. 1, permanentlyfitted on the stoppered container;

FIG. 4 represents the container with its connection device from which alid has been removed.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

A device 1 according to the present invention has a dual function. Onthe one hand, it tamperproofs a container 2, for example a glass bottle,containing a product, not represented, and which has previously beenclosed or stoppered; this may, for example, be a conventional bottlecontaining a medicinal product in the form of a powder, closed orstoppered, as it leaves the production line or equipment for packagingthis same medicinal product. In use, it also allows a sealed connectionto be provided or set up between the inside of the container 2, on theone hand, and the inside of another vessel (not represented) on theother hand, for example a flexible pouch containing a liquid in whichthe aforementioned medicinal product is intended to be dissolved orsuspended. The result of this is that the container 2 does not have itsown tamperproofing means.

This bottle 2 includes a neck 3, the opening 3a of which is plugged by astopper 4, in a sealed manner. This stopper 4 is made of a relativelysoft material, for example an elastomer such as rubber. The neck 3around its opening 3a has an external annular lip 3b serving, asdescribed below, for fitting and fixing the connection device accordingto the invention. The stopper 4 has a cylindrical central part 4adesigned for being fitted flexibly and in a sealed manner inside theneck 3, and a flattened external part 4b which lies against the annularlip 3b.

A connection device according to the invention essentially comprises:

an internal cap 5 designed to fit coaxially over and fix onto the neck 3of the container 2, plugged with the stopper 4,

means 9 for connection with the inside of the container 2, through thestopper 4, these means being arranged and interacting with the internalcap 5,

an external sleeve 10 designed to slide coaxially against and on theoutside of the internal cap 5, and to fit permanently over the latter,tightly gripping the cap 5,

a protection means or lid 12 for the connection means 9, fitted on theexternal sleeve 10.

The internal cap 5 and the external sleeve 10 are each made as a singlepiece of a plastic, or of a material which is relatively hard, bycomparison with the material of the stopper 4 which is relatively soft.In particular, the external sleeve 10 is made of a plastic having arelatively high elastic modulus, for example a technical-grade plasticsuch as a polyamide or a high-density polyethylene, while the internalcap is made of a plastic which has a lower elastic modulus, for examplea low-density polyethylene.

The internal cap 5 comprises catching teeth 6, separated from oneanother and distributed angularly about the axis 7 of the cap, which isthe axis of the connection device 1, and together forming a skirt ofcylindrical shape. Each tooth 6 has elasticity radially outwards so thatit can snap-fasten (cf. FIG. 3) under the annular lip 3b of the neck 3.

As represented in FIG. 1, the catching teeth 6, and therefore thecylindrical skirt which they form, therefore have a normal position,that is to say a position which is not stressed radially outwards, whichcorresponds to direct contact with the neck 3 and underneath the annularlip 3b. However, they have elasticity radially outwards pulling themback centripetally towards the neck 3, and allowing them to negotiatethe flattened external part 4b of the stopper 4 and the annular lip 3bof the stopper 4 when the internal cap 5 is pushed down over the neck 3of the container.

Each catching tooth 6 has an internal heel 6b with a shape designed tointeract with the lower rim of the annular lip 3b. The internal cap 5also includes, as a single piece with the catching teeth 6, a relativelyrigid transverse wall 8 for resting against the flat external part 4b ofthe relatively soft stopper 4. A central opening 8a is made in the wall8 in relation to the connection means 9 described later. This centralopening 8a forms, with the rest of the internal cap 5, an annular flankfor resting against the flattened external part 4b, of the stopper 4.This annular flank has a circumferential and continuous rib 8b on thestopper 4 side, intended at least partially to penetrate the relativelysoft material of the stopper 4.

The external sleeve 10 is designed to slide coaxially against and on theoutside of the skirt formed by the catching teeth 6 of the internal cap5. This external sleeve 10 has a circumferentially continuous band 10aprovided along one of its edges, namely its free edge, with an internalannular ridge 11 which may be continuous or discontinuous forsnap-fastening under the free rim 6a of the internal cap 5 or, morespecifically, of its catching teeth 6. As represented in FIG. 3, oncethe external sleeve 10 is permanently fitted on the internal cap 5, withthe internal annular ridge 11 snap-fastened under the catching teeth 6,the latter are protected and are no longer visible or accessible fromthe outside. This band 10a, for example made of plastic, is radiallyelastic enough to be fitted tightly over the internal cap 5, grippingthe latter tightly towards the position in which the annular ridge 11 issnap-fastened, but strong enough to be indivisible, unless the externalsleeve 10 and therefore the band 10a is permanently destroyed. Theconsequence of this is that when the external sleeve 10 is in itsposition fitted onto the internal cap 5, the band 10a radially grips thecatching teeth and the corresponding skirt centripetally against theneck 3 of the container 2, which is itself strong and rigid, because itis made of glass, for example. As stated earlier, the external sleeve10, and in particular the band 10a, are made of a material which hasgood mechanical properties, so that they are continuous and have no lineor region of weakness as regards the band 10a, which gives the latterthe properties of being tear-proof and indivisible, unless of course theband 10a is permanently destroyed, for example using a cutting tool orinstrument.

The protecting means or lid 12 is fitted on the external sleeve 10, atthe opposite end from the internal annular ridge 11, with the use of ameans 13 for manually separating the lid from the sleeve 10. As anon-exclusive preference, the lid 12 and the external sleeve 10 areconstructed as a single piece made of plastic with a perforatedcircumferential ring of weakness separating them, and forming the means13 of manual separation defined earlier. The protecting means or lid 12is fitted in sealed contact on the outside and with the collar 14described later, forming part of the connection means 9. This sealedcontact, especially sealed against any liquid, is obtained using anyappropriate means known per se, for example using steppedcircumferential slender strips obtained directly by moulding on theoutside of the collar 14 and engaged with the internal bearing surfaceof the lid 12.

Means 30 for preventing translational movement are arranged between theexternal sleeve 10 and the collar 14 of the cap 5 so that theycomplement the internal annular ridge 11 in the position in which theexternal sleeve 10 is fitted over the internal cap 5. These meansconsist of a circumferential rib projecting inside the internal sleeve10 and a corresponding circumferential groove formed around the outsideof the collar 14. All of this, together with the internal annular ridge11 allows the external sleeve 10 to be immobilized permanently in termsof translation on the internal cap 5.

Means 31 for preventing rotational movement are arranged between theexternal sleeve 10 and the internal cap 5, when the external sleeve 10is in its position fitted on the cap. These means, which have not beenrepresented, include for example internal longitudinal ribs on theexternal sleeve 10 interacting with corresponding suitable externallongitudinal grooves made on the collar 14. These arrangements make itpossible to block the external sleeve 10 in terms of rotation in itsposition fitted on the internal cap 5, which makes it possible to avoiddigging into the stopper 4 or forming therein a depression which wouldbe detrimental to sealing, in register with the rib 8b.

To make the assembly of the connection device, followed by its permanentfitting on the closed container easier to perform automatically, theinternal cap 5 includes or defines a slot 24 designed to take theinternal annular ridge 11 of the external sleeve 10 and allow temporaryand coaxial assembly of the cap 5 and of the sleeve 10.

The connection means comprise, on the one hand, a collar 14 lengtheningthe internal cap 5 in a one-piece and coaxial manner and forming aninternal bore 14a and, on the other hand, a piston 15 mounted so that itcan slide in the bore 14a between a disconnected position represented inFIGS. 3 and 4, in which the piston is at the opposite end to and somedistance away from the stopper 4, and a connected position, notrepresented, in which the piston 15 is arranged on the same side andagainst the stopper 4, and its flattened exterior part 4b. A central orcoaxial needle 16 passes through the piston 15 and has one end 16a forperforating the stopper 4 and another end 16b for connection, forexample, with another container, especially a flexible pouch for aliquid for example. This needle 16 is made of metal or of plastic withone or two flow ducts. The connection end 16a and/or 16b is possiblydesigned to avoid the loosing of particles or fragments resulting fromthe perforating of the stopper 4. As shown by FIGS. 2 and 3, the lid 12and the internal cap 5 are designed one with respect to the other tocontain the connection means 9 in their position disconnected from theinside of the container 2, that is to say with the piston 15 arrangedsome distance from the stopper 4, without any penetration of theperforating end 16a of the needle 16 in the said stopper.

In the configuration of the device according to the present invention asrepresented in FIG. 3, ready for use and tamperproof, the internal bore14a of the collar 14, the piston 15 in its position some distance awayfrom the stopper 4, the external face thereof bounded by the annularflank of the transverse wall 8a of the internal cap 5 together delimit achamber 32 in which the end 16a of the needle 16 is arranged without anyspecial protection, especially perforable flexible end piece. This end16a is therefore directly facing the stopper 4. The sealing of thischamber 32 to external fluids is provided, on each side of the collar14, by the lid 12 mounted in a sealed manner on the collar 14, and bythe hard/soft bearing of the transverse wall 8, particularly of the rib8b which partially penetrates the stopper 4. This seal makes itpossible, through the time that the container 2 is stored with thedevice according to the invention, to maintain the sterile conditionswithin the chamber 32, and in particular of the external surface of thestopper 4 and of the perforating end 16b which when the connection means9 are activated will come into contact with one another.

As represented in the figures, the piston 15 comprises a transverse webthrough which the needle 16 passes, and an external sleeve tube 15bopposite the stopper 4 which guides any end piece of another container,for example a pouch of fluid with which the inside of the container 2 isconnected.

The assembly followed by the fitting of the connection device 1previously described on the container 2 takes place, especially in anautomatic fashion, as follows:

the piston 15 with the needle 16 is arranged and fitted in the "up"position inside the bore 14a of the collar 14, of a single piece withthe internal cap 5;

the external sleeve 10, of a single piece with the lid 12 is temporarilyfitted on the internal cap 5 using the annular ridge 11 snap-fastened inthe groove 14 of the internal cap 5;

the connection device 1, thus temporarily fitted is snap-fastened underthe annular lip 3b of the container 2, using the catching teeth 6 of thecap;

under continuing axial thrust on the lid 12, the band 10a of the sleeve10 fits permanently and tightly on and around the skirt formed by theexternal parts of the teeth 6 with the annular ridge 11 snap-fastenedunder the rim 6a of the cap 5 (cf. FIG. 3).

From this moment, the container 2 is rendered tamperproof because theinternal cap 5 can be detached from the container 2 only by breaking andtherefore destroying the band 10a, without the user having thepossibility of reconstructing the sealing device 1. In this permanentconfiguration, the inside of the collar 14 is permanently isolated fromthe outside in a sealed manner, particularly with regard to fluids,which in particular makes it possible to preserve its sterility. Inparticular, small relative movements of the device 1 according to theinvention with respect to the container 2 are unable to break this seal.

In this configuration too, the internal cap 5 is fitted directly overthe neck 3 of the container, in contact with the glass, without theinterposition of any other tamperproofing means such as a tearable metalor plastic collar. The same is true of the transverse wall 8 of theinternal cap 5 which rests directly against the external part of thestopper 4.

At the time of the first use, by separating the lid 12 from the sleeve10 along the dividing line 13, in accordance with FIG. 4, the container2 is ready for use, on account of the accessibility of the connectionmeans 9, which in particular can then be activated into it connectedposition by pushing the piston 15 down towards the stopper 4, insertingthe end 16b of the needle 16 in the end piece of some other container orpouch.

Various tests conducted with a connection device according to theinvention and as described earlier have shown that this device remainedsealed and constituted an effective microbe-proof barrier against anyexternal contamination.

What is claimed is:
 1. Device for connection to a closed container, saidcontainer comprising a neck an opening of said neck being plugged by astopper made of relatively soft material, and provided with an externalannular lip, the connection device comprising:a cap designed to fitcoaxially over the neck of the container plugged with the stopper,elastic radially outwards so that it can snap-fasten over the annularlip of the neck, the cap comprising a coaxial collar lengthening it andforming an internal bore, a transverse wall for coming into contact withan external part of the stopper, and means for connection with theinside of the container through the stopper, comprising a piston mountedso that it can slide in a bore of the collar of the cap, a centralneedle passing through the piston and having one end for perforating thestopper, wherein in combination, the cap is designed to fit directlyover the neck of the container, the transverse wall is made of arelatively hard material for coming directly to bear against theexternal part of the stopper and includes a central opening for thepassage of the central needle of the connection means, and the devicefurthermore includes, on the one hand, an external sleeve designed toslide coaxially against and on the outside of the internal cap,including a circumferentially continuous band provided along one of itsedges with an internal annular ridge for snap-fastening under a free rimof the internal cap which is radially elastic enough to fit tightlyagainst the internal cap and snap-fasten by means of the annular ridgeunder the free edge but is strong enough to be indivisible and means forprotecting the connection means from the outside, in leaktight contactwith the collar of the cap.
 2. Device according to claim 1, wherein thetransverse wall is constructed as a single piece, made of plastic, withthe internal cap.
 3. Device according to claim 1, wherein the transversewall comprises a continuous circumferential rib intended to penetrate,at least partially, the relatively soft material of the stopper. 4.Device according to claim 1, further comprising means for preventingtranslational movement arranged between the external sleeve and thecollar of the cap, said means complementing the internal annular ridgein a position where the external sleeve is fitted tightly on theinternal cap.
 5. Device according to claim 1, further comprising meansfor preventing rotational movement arranged between the external sleeveand the internal cap in a position where the external sleeve is fittedtightly on the internal cap.
 6. Device according to claim 1, wherein theinternal cap comprises catching teeth distributed angularly about anaxis of the cap, each tooth having elasticity radially outwards so thatit can come into a position where it is snap-fastened under the annularlip of the neck.
 7. Device according to claim 1, wherein the protectionmeans includes a lid fitted over the external sleeve and means formanually separating the lid from the sleeve.
 8. Device according toclaim 7, wherein the lid and the external sleeve are constructed as asingle piece made of plastic, with a perforated circumferential ring ofweakness separating them and forming the means for manual separation. 9.Device according to claim 1, wherein the central needle has another endfor connecting with another container.
 10. Ready-for-use assemblycomprising a closed container containing a product, said containerincluding a neck, the opening of which is plugged by a stopper made ofrelatively soft material and provided with an external annular lip, anda connection device according to claim 1, mounted permanently on saidcontainer, by means of the external sleeve being fitted tightly over theinternal cap, itself snap-fastened under the annular lip of thecontainer.